Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT03870269
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total operative time', 'timeFrame': 'During procedure, not to exceed 12 hours'}], 'secondaryOutcomes': [{'measure': 'Blood loss (measured in cubic centimeters)', 'timeFrame': 'Measured at end of procedure, not to exceed 12 hours'}, {'measure': 'Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure', 'timeFrame': 'During procedure, not to exceed 12 hours'}, {'measure': 'Intraoperative complication', 'timeFrame': 'During procedure, not to exceed 12 hours'}, {'measure': 'Patient hospital stay', 'timeFrame': 'Measured at time of patient discharge, up to 10 days'}, {'measure': 'Positive tumor margin (assessed via standard post-operative biopsy)', 'timeFrame': 'Measured 1-2 weeks after discharge'}, {'measure': 'Postoperative Gleason Score', 'timeFrame': 'Measured up to 3 months after discharge'}, {'measure': 'Postoperative oncologic stage (T stage)', 'timeFrame': 'Measured up to 3 months after discharge'}, {'measure': 'Readmission', 'timeFrame': 'Measured up to 6 months after discharge'}, {'measure': 'Postoperative prostate-specific antigen (PSA)', 'timeFrame': 'Measured up to 12 months after disccharge'}, {'measure': 'Postoperative erectile function', 'timeFrame': 'Measured via survey up to 18 months after discharge'}, {'measure': 'Postoperative continence', 'timeFrame': 'Measured via survey up to 18 months after discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is undergoing robotic prostatectomy being performed by participating surgeon\n* Patient is willing to be randomized between intervention and control arms\n\nExclusion Criteria:\n\n* Patients with prior pelvic radiation\n* Patients with prior androgen deprivation therapy\n* Patients with prior localized ablative therapy\n* Patients with prior TURP or other surgical BPH treatment'}, 'identificationModule': {'nctId': 'NCT03870269', 'briefTitle': 'Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ceevra, Inc.'}, 'officialTitle': 'Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC', 'orgStudyIdInfo': {'id': '17-0904RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.', 'interventionNames': ['Device: Ceevra Reveal']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Subjects whose surgeon will only be viewing CT/MR images in connection with the case.'}], 'interventions': [{'name': 'Ceevra Reveal', 'type': 'DEVICE', 'description': 'VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Hospital', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Eric Wallen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ceevra, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}